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Trial record 1 of 1 for:    NCT00485472
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Trial to Assess Efficacy and Safety of Lacosamide in Subjects With Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT00485472
Recruitment Status : Terminated (Based on the outcome of the planned first interim analysis, it was decided not to continue the trial. No safety concerns were identified.)
First Posted : June 13, 2007
Results First Posted : September 22, 2009
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE June 12, 2007
First Posted Date  ICMJE June 13, 2007
Results First Submitted Date  ICMJE August 12, 2009
Results First Posted Date  ICMJE September 22, 2009
Last Update Posted Date August 28, 2017
Study Start Date  ICMJE March 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2010)
Change of the Western Ontario and McMaster Universities (WOMAC) Pain Subscale Score (Visual Analogue Scale Version) From Baseline to the End of the 8 Week Maintenance Period [ Time Frame: Baseline, end of 8 week Maintenance Period ]
The Visual Analogue Scale (VAS) version of the WOMAC pain subscale ranges from 0 to 100, high values describe high grade of pain.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2010)
  • Change From Baseline to End of 8 Week Maintenance Period in WOMAC Physical Function Subscale Score. [ Time Frame: Baseline, end of 8 week Maintenance Period ]
    The WOMAC physical function subscale score (Visual Analogue Scale version) ranges from 0 to 100, high values describe high grade of difficulty in performing daily activities.
  • Change From Baseline to End of 8 Week Maintenance Period in WOMAC Stiffness Subscale Score. [ Time Frame: Baseline, end of 8 week Maintenance Period ]
    The WOMAC stiffness subscale score (Visual Analogue Scale version) ranges from 0 to 100, high values describe high grade of stiffness.
  • Change From Baseline to End of 8 Week Maintenance Period in Total WOMAC Score. [ Time Frame: Baseline, end of 8 week Maintenance Period ]
    The WOMAC total score is the sum of the normalized subscale scores for pain, stiffness, and physical function and ranges from 0 to 300, high values describe high grade of impact.
  • Patient's Global Impression of Change From Baseline at the End of 8 Week Maintenance Period. [ Time Frame: at the end of 8 week Maintenance Period ]
    Patient's global impression of change from baseline is a score that ranges from 'very much worse' to 'very much improved'.
  • Response at the End of 8 Week Maintenance Period Versus Baseline Based on the (Slightly Modified)Criteria of the Osteoarthritis Research Society International (OARSI) and the Outcome Measures in Rheumatology Initiative (OMERACT). [ Time Frame: Baseline, end of 8 week Maintenance Period ]
    Improvement = reduction of >= 20% and >= 10 mm in both WOMAC pain and physical function subscale. Those who met the criteria in either of the subscales had improved if response to Patient's Global Impression of change from baseline was at least 'mildly improved'. High improvement = reduction of >= 50% and >= 20 mm in either of the subscales. Response = either high improvement or improvement.
  • Amount of Rescue Medication Use During 8 Week Maintenance Period. [ Time Frame: during 8 week Maintenance Period ]
    Use of rescue medication is expressed in number of tablets equivalent to 500 mg Paracetamol per day.
  • Change From Baseline to End of 8 Week Maintenance Period in Perception of Pain Interference With Subject's Sleep. [ Time Frame: Baseline, end of 8 week Maintenance Period ]
    Pain interference with sleep refers to patient's last evening prior to the visit and was assessed using a 100mm visual analog scale (VAS). The VAS ranges from 0 (did not interfere) to 100 (completely interfered).
  • Change From Baseline to End of 8 Week Maintenance Period in Profile of Mood States (Total Mood Disturbance Score). [ Time Frame: Baseline, end of 8 week Maintenance Period ]
    Total Mood Disturbance score sums up over the domain scores regarding Tension-anxiety, Depression-ejection, Anger-hostility, Vigor-activity (was subtracted), Fatigue-inertia, Confusion-bewilderment. Domain scores were derived as sum of the respective items and range from 0 to 20. With exception of Vigor-activity high values describe bad mood.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Assess Efficacy and Safety of Lacosamide in Subjects With Osteoarthritis of the Knee
Official Title  ICMJE A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Osteoarthritis of the Knee
Brief Summary The purpose of this trial is to evaluate the effectiveness, safety and tolerability of lacosamide (LCM) 400mg/day in treating the signs and symptoms of osteoarthritis of the knee.
Detailed Description

LCM is an investigational drug that is being studied as a treatment in male and female patients who are diagnosed with osteoarthritis of the knee and require therapeutic doses of NSAIDs, COX-2 NSAIDs and/or paracetamol. This trial will be conducted exclusively in Europe.

The study has an adaptive 3-stage group sequential design.

The trial will last a total of 17 weeks. There will be a 2 week period to wean off current medication, followed by a 4 week period where the patient will receive placebo (inactive drug) or gradually increasing doses of LCM up to the target dose of 400mg/day. The target dose or placebo will be maintained for 8 weeks followed by a 1 week reduction period then a 2 week safety follow up period.

The last subject is expected to be enrolled in December 2007.

The study was terminated based on the outcome of the planned first interim analysis, which was performed as defined in the protocol in a subset of patients. It was decided not to continue the trial. No safety concerns were identified.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Drug: lacosamide
    50 or 100mg tablet, 400mg daily, for 12 weeks
    Other Name: VIMPAT
  • Other: Placebo
    50 or 100mg tablet, 400mg daily, for 12 weeks, matched to Lacosamide
Study Arms  ICMJE
  • Experimental: Lacosamide
    lacosamide (LCM)
    Intervention: Drug: lacosamide
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 12, 2009)
194
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject has symptomatic osteoarthritis of the knee diagnosed using clinical and radiographic evidence as well as ACR criteria with symptom duration of at least 6 months.
  • Subject requires therapeutic dose of an NSAID, COX-2 NSAID, and/or paracetamol/acetaminophen for osteoarthritis pain of the index knee and has taken that medication at least 5 days per week for the last 4 weeks prior to the screening visit (Visit 1).

Exclusion Criteria:

  • Subject is not able to withdraw NSAIDs, COX-2 NSAIDs and/or paracetamol
  • Subject is taking analgesic other than NSAIDs COX-2 NSAIDs and/or paracetamol
  • Subject is planning to begin or stop treatment with glucosamine and/or chondroitin during the trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Germany,   Hungary,   Poland,   Romania,   Sweden,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00485472
Other Study ID Numbers  ICMJE SP0905
2006-005048-97 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP